Onur Medikal Sanayi ve Ticaret Anonim Şirketi

Onur Medikal specializes in spinal orthopedic devices, specifically non-bioabsorbable spinal bone screws and connectors for internal spinal fixation systems. These products are primarily used in surgical procedures to stabilize the spine, helping patients recover from spinal injuries or conditions requiring structural support.

Onur Medikal Sanayi is headquartered in Turkey, where it designs and manufactures its spinal fixation devices. The company’s location influences its regulatory compliance, particularly under EU standards if its devices are marketed there.

Onur Medikal’s devices are registered in the EUDAMED database, which is the European Union’s transparency system for medical devices. This registry is used to track devices authorized under EU regulations, including their classification and compliance details.

Onur Medikal’s spinal bone screws and connectors fall under Class IIb classification in the EU. This classification applies to devices that pose a moderate risk to patients and require rigorous conformity assessment procedures, such as clinical evaluations and manufacturer quality system audits, to ensure safety and performance.